Zai Lab’s Efgartigimod NDA Accepted by NMPA for Myasthenia Gravis
Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the National Medical Products Administration (NMPA)...
Drug
Zhejiang Medicine’s ARX305 ADC Receives Clinical Trial Approval for CD70-Positive Cancers
China-based Zhejiang Medicine Co., Ltd (SHA: 600216) announced that its subsidiary NovoCodex Biopharmaceuticals Ltd has...
Abbisko Therapeutics’ ABSK021 Receives BTD for Giant Cell Tumor Treatment
Shanghai-based Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that its Category 1 drug ABSK021 has...
HutchMed’s Orpathys-Tagrisso Combo Shows Promise in NSCLC at WCLC
China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the publication of an abstract detailing the SAVANNAH...
Junshi Biosciences’ JS203 Bispecific Antibody Receives NMPA Green Light for NHL Study
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the National Medical Products Administration (NMPA)...
Eli Lilly’s Trulicity + Insulin Combo Meets Goals in China’s AWARD-CHN3 Study
Eli Lilly (NYSE: LLY) announced that its Phase III AWARD-CHN3 study of Trulicity (dulaglutide) combined...
CDE Grants Priority Review to Ascentage’s Olerembatinib and Roche’s Crovalimab
The Center for Drug Evaluation (CDE) has granted priority review status to two drugs: Suzhou...
Hengrui Medicine’s SHR-1701 + Ameile Combo Greenlit for EGFR-Mutated NSCLC Trial
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that the National Medical Products Administration...
Eucure Biopharma Doses First Patient in YH003 + Keytruda Trial for Mucosal Melanoma
Eucure Biopharma, a subsidiary of Sino-US contract research organization Biocytogen, announced that the first patient...
Overland ADCT BioPharma Launches Global Phase III Trial for Zynlonta in DLBCL
Overland ADCT BioPharma, a joint venture between China’s Overland Pharmaceuticals and Switzerland’s ADC Therapeutics SA...
Bio-Thera Solutions Doses First Patient in BAT8006 Phase I Study for Solid Tumors
Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that the first patient has been dosed in a...
OBI Pharma Halts OBI 888 Trial Over Manufacturing Costs, Shifts Focus to Globo H ADC
Taiwan-based OBI Pharma (TPEx: 4174) announced the discontinuation of a Phase I/II trial for its...
Hengrui Medicine’s SHR8554 Accepted for NMPA Review in Postoperative Pain
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that its market filing for SHR8554,...
CSPC Pharmaceutical’s JMT103 Anti-RANKL Antibody Prioritized for CDE Review
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its market filing for JMT103, an...
Gan & Lee Pharmaceuticals’ GZR4 Ultra-Long-Acting Insulin Receives Clinical Trial Approval
China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that its Category 1 therapeutic biologic product...
VivaVision Biotech’s VVN539 Enters Phase II Trial for Open-Angle Glaucoma in US
China’s VivaVision Biotech Inc. announced the first patient enrollment in a Phase II clinical study...
Neurophth’s NR082 Gene Therapy Receives BTD for Leber Hereditary Optic Neuropathy
China’s Center for Drug Evaluation (CDE) has awarded breakthrough therapy designation (BTD) to Wuhan Neurophth...
Biotheus Inc.’s PM1009 Bispecific Antibody Enters Clinical Trial Review for Solid Tumors
China-based Biotheus Inc. announced that its clinical trial filing for PM1009, a bispecific antibody (BsAb)...
Innovent Biologics’ Pemazyre Becomes First FGFR2 Inhibitor Approved in China
China-based Innovent Biologics Inc. (HKG: 1801) announced that the first prescription has been filled in...
Dizal Pharma’s DZD1516 Receives NMPA Green Light for HER2+ Breast Cancer Trial
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192), spun out from AstraZeneca’s China drug discovery unit...